Scientific Director (SERM & Clinical Safety & Pharmacovigilance) - Remote - Based in Brazil

Alphanumeric; Brasil; Remote; BRL 180,000 - 250,000; Full time

Job summary

Alphanumeric is seeking a SERM Scientific Director to lead safety evaluation, risk management and pharmacovigilance programs across global clinical development and post‑marketing activities. The role requires independent handling of safety issues and strategic safety decision‑making with regulatory bodies.

Strong English communication and cross‑functional collaboration are essential. The position is remote, based in Brazil, with a 1-year contract and potential extension.

Qualifications

• Advanced degree in science or healthcare field.
• Significant experience in clinical development and pharmacovigilance.
• Experience responding to Health Authority RFIs.
• Strong regulatory and protocol support experience.
• Excellent analytical, scientific writing and communication skills.
• Fluency in English is mandatory.
• Ability to work independently and escalate issues when needed.
• Experience in global cross-functional teams.

Responsibilities

• Lead safety review and risk management activities for assigned products.
• Evaluate safety data from trials, post‑marketing sources and literature.
• Support global regulatory submissions and health authority interactions.
• Draft and review responses to RFIs from Health Authorities.
• Provide protocol, safety and regulatory support to clinical teams.
• Participate in cross‑functional safety governance and risk management.
• Identify emerging safety concerns and recommend actions.
• Collaborate to ensure scientifically sound, compliant safety strategies.

Education

Advanced degree (PhD/PharmD/MS/NP/RN)

Job description

About the role

Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization. This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs.

The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.

Location

Remote, based in Brazil.

Employment Type

Full-Time | 1-Year Contract | Potential Extension

Working Hours

Candidates must be available to work within U.S. and/or U.K. business time zones.

Key Responsibilities

• Lead safety review and risk management activities for assigned products.
• Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
• Support global regulatory submissions and health authority interactions.
• Draft and review responses to Health Authority Requests for Information (RFIs).
• Provide protocol, safety, and regulatory support to clinical development teams.
• Participate in cross-functional safety governance and risk management activities.
• Identify emerging safety concerns and recommend appropriate actions.
• Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies

Required Qualifications

• Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent).
• Significant experience in clinical development, drug safety, pharmacovigilance, or a related field.
• Experience responding to Health Authority RFIs.
• Strong protocol support and regulatory experience.
• Excellent analytical, scientific writing, and communication skills.
• Proficiency in English is mandatory.
• Ability to work independently and appropriately escalated issues when needed.
• Experience working effectively within global cross-functional teams

Preferred Qualifications

• Oncology experience is highly desirable but not required.
• Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
• Experience supporting global development programs.